FDA product code IPR: Crutch
IPR is the FDA product code for crutch. It is a Class I device, regulated under 21 CFR 890.3150 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under IPR, from 3 different applicants. The average 510(k) review took 19 days (median 16). FDA has posted 5 recalls for IPR devices.
Classification
| Field | Value |
|---|---|
| Device name | Crutch |
| Device class | Class I |
| Regulation | 21 CFR 890.3150 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IPR clearance
Top IPR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maddak, Inc. | 2 | 1979-04-03 |
| Manuco Manufacturing Co., Inc. | 1 | 1982-06-21 |
| Husa Folding Crutch Co., Inc. | 1 | 1980-02-22 |
Most recent IPR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821403 | Manuco Manufacturing Co., Inc. | LIGHT WEIGHT ALUMINUM CRUTCHES | 1982-06-21 | 41 |
| K800237 | Husa Folding Crutch Co., Inc. | FOLDING CRUTCH | 1980-02-22 | 17 |
| K790557 | Maddak, Inc. | CRUTCH | 1979-04-03 | 15 |
| K770146 | Maddak, Inc. | SWIVEL HEAD ADJUSTABLE CRUTCH | 1977-01-28 | 4 |
Recalls for IPR devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-08-04.
Frequently asked questions
What is FDA product code IPR?
IPR is the FDA product code for crutch. It is a Class I device, regulated under 21 CFR 890.3150 and reviewed by the Physical Medicine panel.
What device class is IPR?
Class I, regulation 21 CFR 890.3150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPR?
Across 4 cleared submissions the average was 19 days from receipt to decision (median 16).
Which companies have the most IPR clearances?
Maddak, Inc. (2); Manuco Manufacturing Co., Inc. (1); Husa Folding Crutch Co., Inc. (1).
Have IPR devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2004-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code IPR
- Run a recall and safety report across every IPR manufacturer
- Watch product code IPR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times